Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes

This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).

NCT Number	NCT06936657
Lead Sponsor	Shanghai 6th People's Hospital
Conditions	Type 2 Diabetes Mellitus (T2DM)
Enrollment	150 participants
Start Date	2025-10-20
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-12